Biotech Values

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Exel has 2 oral presentations at ASCO this is the other one.

Also, the RET Lung had 5/18 partial response---It appears Exelixis will not be able to get a phase 2 registration off of 28% response rate.

http://abstracts.asco.org/156/AbstView_156_147349.html

Background: RET rearrangements are found in 1-2% of non-small cell lung cancers and are drivers of growth in vitro and in vivo. Cabozantinib is a multi-tyrosine kinase inhibitor with activity against RET. Methods: This is a single-institution, open-label, phase II trial. Eligible patients (pts) had stage IV RET-rearranged lung cancer, KPS > 70%, and measurable disease (RECIST v1.1). Cabozantinib was administered at 60 mg daily until progression or unacceptable toxicity. Study endpoints included response at 12 weeks, objective response, progression-free survival (PFS), overall survival (OS), and toxicity. Simon two-stage minimax design: H0 10% vs HA 30% overall response rate (ORR). Five responses of a maximum of 25 patients were required to meet the primary endpoint. Results: Twenty pts were treated. The median age was 56 (range 38-80 years). All pts had adenocarcinoma and 60% (12/20) were female. The median number of prior chemotherapy lines was 1 (range 0-5). There were no complete responses. The rate of any partial response (PR) at 12 weeks was 33% (5/15, 95% CI 12-62%). ORR was 28% (5/18, 95% CI 10-53%) with 5 confirmed PRs. Stable disease rate was 72% (13/18, 95% CI 51-93%) including 2 unconfirmed PRs. Median PFS was 7 mo (95% CI 3 mo-not reached). Median OS was not reached. Toxicities were mostly grade 1 or 2 and included fatigue, diarrhea, palmar-plantar erythrodysesthesia, transaminitis, and thrombocytopenia. At least 1 dose reduction was required in 60% (12/20) of pts. Eight patients remain on treatment between 1 and 23 mo. Conclusions: Cabozantinib is active in patients with RET-rearranged lung cancers and responses can be durable. This study has met its primary endpoint. A larger, confirmatory, multi-center trial is now warranted. Clinical trial information: